Effectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a real-world prospective observational study in South Korea
Abstract Background Intestinal Behçet’s disease (BD) is characterized by typical gastrointestinal ulcers in patients with BD followed by complications such as bleeding, perforation and fistula. Biologic agents are currently under active investigation to delay the disease course. Various data regardi...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-12-01
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| Series: | BMC Gastroenterology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12876-023-03090-x |
| _version_ | 1827399478752051200 |
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| author | Jongwook Yu Sung Jae Shin Yune-Jung Park Hyung Wook Kim Bo-In Lee Byong Duk Ye Geun-Tae Kim Sung Kook Kim Joo Sung Kim Young-Ho Kim Seonjeong Jeong Jae Hee Cheon |
| author_facet | Jongwook Yu Sung Jae Shin Yune-Jung Park Hyung Wook Kim Bo-In Lee Byong Duk Ye Geun-Tae Kim Sung Kook Kim Joo Sung Kim Young-Ho Kim Seonjeong Jeong Jae Hee Cheon |
| author_sort | Jongwook Yu |
| collection | DOAJ |
| description | Abstract Background Intestinal Behçet’s disease (BD) is characterized by typical gastrointestinal ulcers in patients with BD followed by complications such as bleeding, perforation and fistula. Biologic agents are currently under active investigation to delay the disease course. Various data regarding infliximab are available, but there is relatively lack of data regarding adalimumab. Methods This was a multicenter, real-world prospective observational study to evaluate the effectiveness and safety of adalimumab in intestinal BD. The primary endpoint was disease activity at each follow up, including disease activity index for intestinal Behçet’s disease (DAIBD), serum C-reactive protein (CRP) level, and endoscopic findings. The secondary endpoint was the incidence of adverse drug reactions (ADRs). Results A total of 58 patients were enrolled and 8 of them were excluded. Adverse events were reported in 72.0% of patients with 122 events. ADRs were reported in 24.0% with 28 events. For adverse events, arthralgia was most commonly reported (13.1%: 16/122) and only one experienced critical adverse event (0.82%, 1/122: death due to stroke). On multivariable regression analysis, a longer disease duration was significantly associated with decreased ADRs [Odds ratio 0.976 (0.953–0.999, 95% CI); p = 0.042]. Clinical response rates as assessed by DAIBD were 90.9% at Week 12 and 89.7% at Week 56, respectively. The mean serum CRP level at baseline was significantly decreased after 12 weeks (3.91 ± 4.93 to 1.26 ± 2.03 mg/dL; p = 0.0002). Conclusion Adalimumab was found to be safe and effective in Korean patients with intestinal BD. A longer disease duration was significantly associated with decreased ADRs. |
| first_indexed | 2024-03-08T19:46:33Z |
| format | Article |
| id | doaj.art-9d039b74ea4c4de78b7af424d3b64c76 |
| institution | Directory Open Access Journal |
| issn | 1471-230X |
| language | English |
| last_indexed | 2024-03-08T19:46:33Z |
| publishDate | 2023-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Gastroenterology |
| spelling | doaj.art-9d039b74ea4c4de78b7af424d3b64c762023-12-24T12:20:22ZengBMCBMC Gastroenterology1471-230X2023-12-012311910.1186/s12876-023-03090-xEffectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a real-world prospective observational study in South KoreaJongwook Yu0Sung Jae Shin1Yune-Jung Park2Hyung Wook Kim3Bo-In Lee4Byong Duk Ye5Geun-Tae Kim6Sung Kook Kim7Joo Sung Kim8Young-Ho Kim9Seonjeong Jeong10Jae Hee Cheon11Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of MedicineDepartment of Gastroenterology, Ajou University School of MedicineDivision of Rheumatology, Department of Internal Medicine, St. Vincent’s Hospital, The Catholic University of KoreaDepartment of Internal Medicine, Pusan National University Yangsan HospitalDivision of Gastroenterology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of KoreaDepartment of Gastroenterology and Inflammatory Bowel Disease Center, Asan Medical Center, University of Ulsan College of MedicineDepartment of Internal Medicine, Kosin University College of MedicineDepartment of Internal Medicine, Kyungpook National University HospitalDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of MedicineDepartments of Medicine, Samsung Medical Center, Sungkyunkwan University School of MedicineAbbVie LtdDepartment of Internal Medicine, Institute of Gastroenterology, Yonsei University College of MedicineAbstract Background Intestinal Behçet’s disease (BD) is characterized by typical gastrointestinal ulcers in patients with BD followed by complications such as bleeding, perforation and fistula. Biologic agents are currently under active investigation to delay the disease course. Various data regarding infliximab are available, but there is relatively lack of data regarding adalimumab. Methods This was a multicenter, real-world prospective observational study to evaluate the effectiveness and safety of adalimumab in intestinal BD. The primary endpoint was disease activity at each follow up, including disease activity index for intestinal Behçet’s disease (DAIBD), serum C-reactive protein (CRP) level, and endoscopic findings. The secondary endpoint was the incidence of adverse drug reactions (ADRs). Results A total of 58 patients were enrolled and 8 of them were excluded. Adverse events were reported in 72.0% of patients with 122 events. ADRs were reported in 24.0% with 28 events. For adverse events, arthralgia was most commonly reported (13.1%: 16/122) and only one experienced critical adverse event (0.82%, 1/122: death due to stroke). On multivariable regression analysis, a longer disease duration was significantly associated with decreased ADRs [Odds ratio 0.976 (0.953–0.999, 95% CI); p = 0.042]. Clinical response rates as assessed by DAIBD were 90.9% at Week 12 and 89.7% at Week 56, respectively. The mean serum CRP level at baseline was significantly decreased after 12 weeks (3.91 ± 4.93 to 1.26 ± 2.03 mg/dL; p = 0.0002). Conclusion Adalimumab was found to be safe and effective in Korean patients with intestinal BD. A longer disease duration was significantly associated with decreased ADRs.https://doi.org/10.1186/s12876-023-03090-xBehçet’s syndromeAdalimumabInflammatory bowel DiseasesTumor necrosis factor-alpha |
| spellingShingle | Jongwook Yu Sung Jae Shin Yune-Jung Park Hyung Wook Kim Bo-In Lee Byong Duk Ye Geun-Tae Kim Sung Kook Kim Joo Sung Kim Young-Ho Kim Seonjeong Jeong Jae Hee Cheon Effectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a real-world prospective observational study in South Korea BMC Gastroenterology Behçet’s syndrome Adalimumab Inflammatory bowel Diseases Tumor necrosis factor-alpha |
| title | Effectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a real-world prospective observational study in South Korea |
| title_full | Effectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a real-world prospective observational study in South Korea |
| title_fullStr | Effectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a real-world prospective observational study in South Korea |
| title_full_unstemmed | Effectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a real-world prospective observational study in South Korea |
| title_short | Effectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a real-world prospective observational study in South Korea |
| title_sort | effectiveness and safety of adalimumab in patients with intestinal behcet s disease a real world prospective observational study in south korea |
| topic | Behçet’s syndrome Adalimumab Inflammatory bowel Diseases Tumor necrosis factor-alpha |
| url | https://doi.org/10.1186/s12876-023-03090-x |
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